Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01591889
First received: May 1, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.


Condition Intervention Phase
Trichomoniasis
Drug: Tinidazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tindamax
500 mg tablet
Drug: Tinidazole
500 mg tablet
Other Name: Tindamax®
Active Comparator: tinidazole
500 mg tablet
Drug: Tinidazole
500 mg tablet
Other Name: Tindamax

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to tinidazole or any comparable or similar product.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591889

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Soran Hong, MD Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01591889     History of Changes
Other Study ID Numbers: TINI-T500-PVFD-1
Study First Received: May 1, 2012
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Trichomonas Infections
Parasitic Diseases
Protozoan Infections
Tinidazole
Alkylating Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitrichomonal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014